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The Global Alliance for TB Drug
Development
Gerald J. Siuta, Ph.D., CLP
Consultant, Business Development
Global Alliance for TB Drug Development
Biotechnology Industry Organization International Convention
Chicago, IL
May 4, 2010
Global Tuberculosis Epidemic
• One-third of the world’s population is infected with
Mycobacterium tuberculosis (M.tb.)
– 2 billion people
• 8-9 million develop active disease annually
• 2 million deaths occur each year
– 1 person dies every 15 seconds
• 400,000 cases of MDR-TB each year
• Leading cause of death in HIV-positive people
– 12 Million people are TB/HIV co-infected
TB’s economic toll: $16 billion a year
Current TB Drug Therapy
• Active TB
– Standard therapy – 4 drugs (isoniazid, rifampin, pyrazinamide &
ethambutol) for 2 months, followed by isoniazid and rifampin for
4 months
• Latent TB
– Standard therapy – isoniazid for 9 months
• Multi-Drug Resistant TB (MDR-TB)
– Individualized, prolonged therapy, few available drugs, poorly
tolerated and difficult to administer
• TB/HIV Co-Infection
– Treatment as in active TB, but drug interactions with
antiretroviral agents make simultaneous therapy difficult
• Extensively Drug Resistant TB (XDR-TB)
– No treatment available
The Need for New TB Drugs
• Complex 6-9 months treatment with a
4 drug combination regimen
• No new anti-TB drug in over 50 years
• TB/HIV co-infections fueling each other
• MDR-TB is on the rise
• Unattractive market for private sector
• No capitalization of public sector research
History of the TB Alliance
• Cape Town Declaration – February 2000
– Hosts: Rockefeller Foundation and the Medical Research
Council of South Africa
– Over 120 organizations (health, science, philanthropy and
private industry)
• Results
– Support goals of Stop TB Initiative
– Create Scientific Blueprint
– Develop Pharmacoeconomic Analysis
Build a Global Alliance for
TB Drug Development
The TB Alliance
• Independent, international Product Development
Partnership founded in October 2000
• Non-profit organization
• Headquarters in New York City
– Offices in Brussels and Cape Town
• Entrepreneurial, virtual R&D approach
– Out-source R&D to public and private partners
• Pro-active fundraising
– Over US $200 million raised
• Support ~ 200 FTE worldwide and 50 FTE in-house
Our Mission
• Develop an entirely new therapeutic
regimen that will shorten or simplify the
treatment of tuberculosis
• Coordinate and act as catalyst for global
TB drug development activities
• Ensure Affordability, Adoption and Access
(AAA Strategy)
AAA Strategy
• Affordability
– Appropriate pricing in developing countries
• Adoption
– Ensure that new drugs are incorporated into
existing treatment programs
• Access
– Procurement and distribution to those patients
who need them most
Our Vision
10 Days
2 Months
6 Months
Profile of a New TB Drug
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Shorten treatment to less than 2 months
Novel mechanism of action (MDR/XDR-TB)
Orally active
Once daily or intermittent therapy
Compatible with HIV treatment
Low cost of goods
Financial Support
• Bill and Melinda Gates Foundation
• Rockefeller Foundation
• Netherlands Ministry for Development
Cooperation
• United States Agency for International
Development (USAID)
• Governments of Great Britain and Ireland
Types of Deals
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In-Licensing
IP Assignment
Sponsored R&D
Collaborative R&D
Freedom to Operate
Clinical Trials
TB Alliance Portfolio
TB ALLIANCE
PROGRAMS
Moxifloxacin
TMC-207
PA-824
Nitroimidazoles
Mycobact. Gyrase Inhibitors
Riminophenazines
InhA Inhibitors
Diarylquinoline
Phenotypic Screening
Tryptanthrins
LeuRS Inhibitors
GyrB Inhibitors
Whole-Cell Screening
Malate Synthase Inhibitors
Menaquinone Syn Inhibitors
Natural Products
RNA Polymerase Inhibitors
Energy Metabolism Inhibitors
Protease Inhibitors
Topoisomerase I Inhibitors
NITD Portfolio
DISCOVERY
Lead
Identification
Lead
Optimization
CLINICAL DEVELOPMENT
Preclinical
Phase I
Phase II
Phase III
Industrial Partners
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Chiron Corporation/Novartis
Bayer Healthcare AG
Tibotec (Subsidiary of Johnson & Johnson)
GlaxoSmithKline
Anacor Pharmaceuticals
Novartis Institute for Tropical Diseases
AstraZeneca
Academic Partners
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New York Medical College
Rutgers University
Colorado State University
Institute of Microbiology (China)
Institute of Materia Medica (China)
Korea Research Institute of Chemical Technology (Korea)
University of Auckland (New Zealand)
University of Pennsylvania
Johns Hopkins University
Infectious Disease Research Institute
University of Illinois at Chicago
Texas A&M University
May 3, 2010
TB Alliance and AstraZeneca
announced that they have entered
into a research collaboration
agreement to accelerate the
discovery, development and clinical
use of drugs against tuberculosis,
especially drug resistant strains.
The Collaboration
• The TB Alliance and AstraZeneca will:
– contribute promising TB drug discovery
projects into a joint portfolio that will be codeveloped
– focus on novel compound classes
– create a seamless path to clinical-stage
development
– share resources
TB Alliance Commitment
• The TB Alliance will contribute its ongoing
collaborations with several world-leading
researchers at:
– University of Pennsylvania
– Rutgers University
– New York Medical College
AstraZeneca Commitment
• Projects will come from its TB research
center in Bangalore, India
• The joint portfolio will be resourced by a
core group of scientists based at
AstraZeneca’s TB research center in
Bangalore, India
Global Alliance for TB
Drug Development
www.tballiance.org